“As of Tuesday, April 1, we had responded to all of the FDA’s information requests and we believe that our [Biologics License ...

Atsena Therapeutics, a clinical-stage gene therapy company focused on using the life-changing power of genetic medicine to reverse or prevent blindness, today announced that the U.S. Food and Drug ...

The FDA approved the use of Opdivo with Yervoy in front-line colorectal cancer, while a Manhattan court junked a class action ...

Tivic Health Systems, Inc. (Nasdaq: TIVC), a diversified therapeutics company, today announced that, on March 28, 2025, it exercised its licensing option for the exclusive, worldwide rights to advance ...

If approved, it will be the first in the US to offer protection ... are ordered and rolled out to the general public, as they ...

Theratechnologies (THTX) announced that the U.S. Food and Drug Administration, FDA, has approved the Company’s Prior Approval Supplement, PAS, ...

The delay dovetails with moves by Republican lawmakers in at least seven states to ban or limit mRNA vaccines. Some, according to KFF Health News, are also pressing regulators to revoke federal ...

The live vaccine is produced from the strain Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN), an attenuated, non-replicating orthopoxvirus.

Novavax started the week hoping the FDA would issue a full approval of its Covid vaccine. But the decision never came.

Key to 400-employee Denali's submission is the FDA allowing measurement of a type of GAG, called heparan sulfate, in ...